- Evaluate investigations, Change Control Requests, Standard Operating Procedures, and Analytical Methods.
- Demonstrate the ability to make quality decisions based on cGMP, regulatory compliance, and site SOPs/documentation.
- Conduct gap analysis of all quality-related procedures to ensure completeness.
- Collaborate with other departments and customers to address feedback on Investigations and Deviations.
- Work with departments to ensure timely revisions and approvals of investigations.
- Assist in document retrieval during audits.
- Provide training to ensure proficient use of the Trackwise system.
- Maintain and report on quality metrics and trends in investigations.
- Review documents to ensure compliance with company standards for formatting, review, approvals, and implementation.
- Lead process improvement initiatives and projects within the company.
- Bachelor's degree in Chemistry or Biology required.
- Preferably at least 3 to 4 years of relevant experience in the pharmaceutical industry, with a focus on writing laboratory investigations and experience with GMP documentation review, Quality Systems, and Health Authority Regulations.
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Quality Assurance Specialist- 221265 - Toms River, United States - Medix
Description
Summary:
The Quality Assurance Specialist will be a member of the Diagnostic Services Unit, responsible for overseeing all lab investigations, deviation reports, and change controls across a variety of different departments to ensure compliance with cGMP and company procedures.
Key Responsibilities:
Qualifications:
